Anchor delivery system

ABSTRACT

A system and associated method for manipulating tissues and anatomical or other structures in medical applications for the purpose of treating diseases or disorders or other purposes. In one aspect, the system includes a delivery device and a plurality of anchor assemblies. The delivery system is configured to deliver a first anchor using loaded energy and reload the energy required to deliver an addition anchor.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/295,395 filed Oct. 17, 2016, now U.S. Pat. No. 10,349,932, which is adivisional of copending U.S. patent application Ser. No. 13/833,299filed Mar. 15, 2013, now U.S. Pat. No. 9,504,461, titled “AnchorDelivery System,” the entire disclosures of which are expresslyincorporated herein by reference.

BACKGROUND OF THE DISCLOSURE

The present disclosure relates generally to medical devices and methods,and more particularly to systems and associated methods for manipulatingor retracting tissues and anatomical or other structures within the bodyof human or animal subjects for the purpose of treating diseases ordisorders.

One example of a condition where it is desirable to lift, compress orotherwise remove a pathologically enlarged tissue is Benign ProstaticHyperplasia (BPH). BPH is one of the most common medical conditions thataffect men, especially elderly men. It has been reported that, in theUnited States, more than half of all men have histopathologic evidenceof BPH by age 60 and, by age 85, approximately 9 out of 10 men sufferfrom the condition. Moreover, the incidence and prevalence of BPH areexpected to increase as the average age of the population in developedcountries increases.

The prostate gland enlarges throughout a man's life. In some men, theprostatic capsule around the prostate gland may prevent the prostategland from enlarging further. This causes the inner end of the prostategland to squeeze the urethra. This pressure on the urethra increasesresistance to urine flow through the end of the urethra enclosed by theprostate. Thus the urinary bladder has to exert more pressure to forceurine through the increased resistance of the urethra. Chronicover-exertion causes the muscular walls of the urinary bladder toremodel and become stiffer. This combination of increased urethralresistance to urine flow and stiffness and hypertrophy of urinarybladder walls leads to a variety of lower urinary tract symptoms (LUTS)that may severely reduce the patient's quality of life. These symptomsinclude weak or intermittent urine flow while urinating, straining whenurinating, hesitation before urine flow starts, feeling that the bladderhas not emptied completely even after urination, dribbling at the end ofurination or leakage afterward, increased frequency of urinationparticularly at night, urgent need to urinate etc.

In addition to patients with BPH, LUTS may also be present in patientswith prostate cancer, prostate infections, and chronic use of certainmedications (e.g. ephedrine, pseudoephedrine, phenylpropanolamine,antihistamines such as diphenhydramine, chlorpheniramine etc.) thatcause urinary retention especially in men with prostate enlargement.

Although BPH is rarely life threatening, it can lead to numerousclinical conditions including urinary retention, renal insufficiency,recurrent urinary tract infection, incontinence, hematuria, and bladderstones.

In developed countries, a large percentage of the patient populationundergoes treatment for BPH symptoms. It has been estimated that by theage of 80 years, approximately 25% of the male population of the UnitedStates will have undergone some form of BPH treatment. At present, theavailable treatment options for BPH include watchful waiting,medications (phytotherapy and prescription medications), surgery andminimally invasive procedures.

For patients who choose the watchful waiting option, no immediatetreatment is provided to the patient, but the patient undergoes regularexams to monitor progression of the disease. This is usually done onpatients that have minimal symptoms that are not especially bothersome.

Surgical procedures for treating BPH symptoms include TransurethalResection of Prostate (TURP), Transurethral Electrovaporization ofProstate (TVP), Transurethral Incision of the Prostate (TUIP), LaserProstatectomy and Open Prostatectomy.

Minimally invasive procedures for treating BPH symptoms includeTransurethral Microwave Thermotherapy (TUMT), Transurethral NeedleAblation (TUNA), Interstitial Laser Coagulation (ILC), and ProstaticStents.

The most effective current methods of treating BPH carry a high risk ofadverse effects. These methods and devices either require general orspinal anesthesia or have potential adverse effects that dictate thatthe procedures be performed in a surgical operating room, followed by ahospital stay for the patient. The methods of treating BPH that carrylower risks of adverse effects are also associated with a lowerreduction in the symptom score. While several of these procedures can beconducted with local analgesia in an office setting, the patient doesnot experience immediate relief and in fact often experiences worsesymptoms for weeks after the procedure until the body begins to heal.Additionally all device approaches require a urethral catheter placed inthe bladder, in some cases for weeks. In some cases catheterization isindicated because the therapy actually causes obstruction during aperiod of time post operatively, and in other cases it is indicatedbecause of post-operative bleeding and potentially occlusive clotformation. While drug therapies are easy to administer, the results aresuboptimal, take significant time to take effect, and often entailundesired side effects.

There have been advances in developing minimally invasive devices andmethods for lifting and repositioning of tissues. However, furtheradvances are necessary to ensure an ability to access difficult to reachbody structure.

There remains a need for the development of new devices and methods thatcan be used to deploy multiple anchors from a single delivery device toimprove the user experience and minimizing patient discomfort. Anability to access anatomy with minimally invasive instruments whileviewing the interventional procedure is also desirable. Moreover,various structures ensuring an effective interventional procedure suchas implants having structural memory characteristics have been found tobe helpful in certain treatment approaches.

The present disclosure addresses these and other needs.

SUMMARY

Briefly and in general terms, the present disclosure is directed towardsan apparatus and method for deploying an anchor assembly within apatient's body to accomplish interventional treatments. A deliverydevice is provided to access the anatomy targeted for the interventionalprocedure. Some embodiments of the delivery device include mechanismsconfigured to deploy one or more anchor assemblies without removing thedevice from the interventional site.

The delivery apparatus of the present disclosure includes varioussubassemblies that are mobilized via an actuator or other manuallyaccessible structure. The operation of the subassemblies is coordinatedand synchronized to ensure accurate and precise implantation of ananchor assembly. In one embodiment, the delivery device is embodied in atissue approximation assembly that is configured to treat BPH.

In one particular aspect, the present invention is directed towards adelivery device that accomplishes the delivery of a first or distalanchor assembly component at a first location within a patient's bodyand the delivery of a second or proximal anchor assembly component at asecond location within the patient. Further, the delivery device caninclude mechanisms for efficient reloading of anchor assembles tominimize patient discomfort and enhance ease of use. The device can alsoaccomplish imparting tension during delivery to a connector to hold itwhile attaching the proximal anchor in situ. The procedure can be viewedemploying a scope inserted in the device. The scope can assume variousconfigurations and can be employed with complementary structureassisting in the viewing function. Also, the delivery device can besized and shaped to be compatible inside a sheath up to 24 F, preferablya 19 F or 20 F sheath or smaller.

The anchor assembly can be configured to accomplish approximating,retracting, lifting, compressing, supporting, remodeling, orrepositioning tissue within the body of a human or animal subject.Moreover, the apparatus configured to deploy the anchor assembly as wellas the anchor assembly itself are configured to complement and cooperatewith body anatomy.

In one aspect, a system for treating a prostate includes a cartridge, ahandle configured to receive the cartridge, and a delivery assembly. Thecartridge includes a distal anchor, a connector, and a proximal anchorand the handle includes an actuator, a spring mechanism loaded withmechanical energy. The delivery assembly includes a member that mateswith the cartridge to transfer the mechanical energy from the springmechanism to the cartridge and the actuator operates to reload themechanical energy.

In one aspect, a system for deploying an anchor assembly includes acartridge carrying the anchor assembly and a handle configured to couplewith the cartridge such that mechanical energy loaded in at least onespring mechanism within the handle is transferred to the cartridge todeploy the anchor assembly. The system includes an actuator configuredto initiate transfer of the mechanical energy and restore the majorityof the mechanical energy to the spring mechanisms.

In one aspect, a method for delivering a plurality of anchor assembliesincludes inserting a cartridge into a handle assembly. The handleassembly includes an actuator and a drive mechanism having a firstloaded configuration characterized by a total stored energy and anunloaded configuration. The cartridge includes at least one anchorassembly and a penetrating member. At least one anchor assembly and thepenetrating member are configured to advance from a distal portion ofthe cartridge. The method includes positioning the distal portion of thecartridge at an interventional site adjacent a prostate and operatingthe actuator to cycle the drive mechanism from the loaded configurationto the unloaded configuration to a second loaded configurationcharacterized by a total stored energy. Operating the actuatorsimultaneously delivers at least one anchor assembly to the prostate bytransferring load from the drive mechanism to the cartridge. The methodincludes removing the cartridge.

Various alternative methods of use are contemplated. The disclosedapparatus can be used to improve flow of a body fluid through a bodylumen, modify the size or shape of a body lumen or cavity, treatprostate enlargement, treat urinary incontinence, support or maintainpositioning of a tissue, close a tissue wound, organ or graft, perform acosmetic lifting or repositioning procedure, form anastomoticconnections, and/or treat various other disorders where a natural orpathologic tissue or organ is pressing on or interfering with anadjacent anatomical structure. Also, the invention has myriad otherpotential surgical, therapeutic, cosmetic or reconstructiveapplications, such as where a tissue, organ, graft or other materialrequires approximately, retracting, lifting, repositioning, compressionor support.

Other features and advantages of the present disclosure will becomeapparent from the following detailed description, taken in conjunctionwith the accompanying drawings, which illustrate, by way of example, theprinciples of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a coronal section through the lower abdomen of a malehuman suffering from BPH showing a hypertrophied prostate gland.

FIG. 1B shows a coronal section through the lower abdomen of a malehuman suffering from BPH showing a hypertrophied prostate gland treatedwith an embodiment of the device of the present invention.

FIG. 1C shows a side view of an embodiment of the retainer shown in FIG.1B.

FIGS. 1D through 1J show the various steps of a method of treating aprostate gland by the retainer shown in FIG. 1C.

FIG. 2 is a perspective view depicting one embodiment of an anchordelivery system.

FIG. 3 is a right side view depicting the anchor delivery system of FIG.2.

FIG. 4 is a perspective view in partial cross-section depicting partialadvancement of a needle assembly.

FIGS. 5-6 illustrate embodiments of a handle assembly for an anchordelivery system that does not pre-load energy in springs while thedevice is in a stored state.

FIGS. 7A-7B are cross-sectional views of features for detecting adamaged needle.

FIG. 8 is a cross-sectional view of two embodiments of a section of anelongate member for an anchor delivery system.

FIG. 9. is a perspective view of a scope lock according to certainembodiments.

FIGS. 10-12 are perspective views depicting features of one embodimentof a cutter assembly of the delivery device.

FIG. 13 is a cross-sectional view depicting positioning of an anchorwithin the cutter assembly.

FIGS. 14-18 are various views depicting further features of a cutterassembly.

FIGS. 19-20 are perspective views depicting features of a suture guide.

FIGS. 21-23 are perspective views depicting features of a pusherassembly.

FIGS. 24A-24E are perspective views depicting features and the operationof a single assembly that acts as a pusher assembly and a cutterassembly.

FIGS. 25A-25J are various views of an anchor delivery system thatincludes a handle configured to accept cartridges.

FIGS. 26A-26E are various views of an anchor delivery system thatincludes cartridges configured to be placed at the distal end of anelongate member of an anchor delivery system.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now to the figures, which are provided by way of example and notlimitation, the present disclosure is directed to a device configured todeliver multiple anchor assemblies within a patient's body for treatmentpurposes. The disclosed apparatus can be employed for various medicalpurposes including but not limited to retracting, lifting, compressing,approximating, supporting, remodeling, or repositioning tissues, organs,anatomical structures, grafts or other material found within a patient'sbody. Such tissue manipulation is intended to facilitate the treatmentof diseases or disorders such as the displacement, compression and/orretraction of the body tissue.

In an aspect of the present disclosure, the delivery device includes ahandle assembly supporting an elongate member. The elongate memberdefines a low profile that is suited to navigate body anatomy to reachan interventional site. Substructure is provided to maintain alongitudinal profile of the elongate member so that the interventionalprocedure can progress as intended.

In another aspect, one portion of an anchor assembly or implant ispositioned and implanted against a first section of anatomy. A secondportion of the anchor assembly or implant is then positioned andimplanted adjacent to a second section of anatomy for the purpose ofretracting, lifting, compressing, approximating, supporting, remodeling,or repositioning the second section of anatomy with respect to the firstsection of anatomy as well as for the purpose of retracting, lifting,compressing, approximating, supporting, remodeling, or repositioning thefirst section of anatomy with respect to the second section of anatomy.It is also to be recognized that both a first and second portion of theanchor assembly can be configured to accomplish the desired retracting,lifting, compressing, approximating, supporting, remodeling, orrepositioning of anatomy due to tension supplied during delivery via aconnector assembly affixed to the first and second portions of theanchor assembly or implant. The delivery device can include an endoscopeproviding the ability to view the interventional procedure.

FIG. 1A shows a coronal section (i.e., a section cut approximately inthe plane of the coronal suture or parallel to it) through the lowerabdomen of a male human suffering from BPH showing a hypertrophiedprostate gland. As depicted in FIG. 1A, the urinary bladder UB is ahollow muscular organ that temporarily stores urine. It is situatedbehind the pubic bone PB. The lower region of the urinary bladder has anarrow muscular opening called the bladder neck which opens into a soft,flexible, tubular organ called the urethra UT. The muscles around thebladder neck are called the internal urethral sphincter. The internalurethral sphincter is normally contracted to prevent urine leakage. Theurinary bladder gradually fills with urine until full capacity isreached, at which point the sphincters relax. This causes the bladderneck to open, thereby releasing the urine stored in the urinary bladderinto the urethra. The urethra conducts urine from the urinary bladder tothe exterior of the body. The urethra begins at the bladder neck andterminates at the end of the penis. The prostate gland PG is locatedaround the urethra at the union of the urethra and the urinary bladder.In FIG. 1A, the prostate gland is hypertrophied (enlarged). This causesthe prostate gland to press on a region of the urethra. This in turncreates an undesired obstruction to the flow of urine through theurethra.

FIG. 1B shows a coronal section through the lower abdomen of a malehuman suffering from BPH showing a hypertrophied prostate gland treatedwith an embodiment of the device of the present invention. It has beendiscovered that the enlarged prostate gland is compressible and can beretracted so as to relieve the pressure from the urethra. In accordancewith one embodiment of the present invention, a retaining device can beplaced through the prostate gland in order to relieve the pressure onthe urethra. In FIG. 1B, a retainer 10 is implanted in the prostategland. Retainer 10 comprises a distal anchor 12 and a proximal anchor14. Distal anchor 12 and a proximal anchor 14 are connected by aconnector 16. The radial distance from the urethra to distal anchor 12is greater than the radial distance from the urethra to proximal anchor14. The distance or tension between the anchors is sufficient tocompress, displace or change the orientation of an anatomical regionbetween distal anchor 12 and proximal anchor 14. The connector 16 can beinelastic so as to maintain a constant force or distance between theproximal and distal anchors or be elastic so as to attempt to draw theproximal and distal anchors closer together. In the embodiment shown inFIG. 1B, distal anchor 12 is located on the outer surface of the capsuleof prostate gland CP and acts as a capsular anchor. Alternatively,distal anchor 12 may be embedded inside the tissue of prostate gland PGor in the surrounding structures around the prostate such as periosteumof the pelvic bones, within the bones themselves, pelvic fascia, coopersligament, muscles traversing the pelvis or bladder wall. Also, in theembodiment shown in FIG. 1B, proximal anchor 14 is located on the innerwall of urethra UT and acts as a urethral anchor. Alternatively,proximal anchor 14 may be embedded inside the tissue of prostate glandPG or surrounding structures as outlined above. Distal anchor 12 andproximal anchor 14 are implanted in the anatomy such that a desireddistance or tension is created in connector 16. This causes distalanchor 12 and proximal anchor 14 to retract or compress a region ofprostate gland PG to relieve the obstruction shown in FIG. 1A. In FIG.1B, two retainers 10 are implanted in prostate gland PG. Each retainer10 is implanted in a lateral lobe (side lobe) of prostate gland PG. Thevarious methods and devices disclosed herein may be used to treat asingle lobe or multiple lobes of the prostate gland or other anatomicalstructures. Similarly, two or more devices disclosed herein may be usedto treat a single anatomical structure. For example, a lateral lobe ofprostate gland PG may be treated using two retainers 10. One or moreretainers may be deployed at particular angles to the axis of theurethra to target one or more lateral lobes and/or middle lobe of theprostate gland. In one embodiment, retainer 10 is deployed between the 1o'clock and 3 o'clock position relative to the axis of the urethra totarget the left lateral lobe of the prostate gland. In anotherembodiment, retainer 10 is deployed between the 9 o'clock and 11 o'clockposition relative to the axis of the urethra to target the right laterallobe of the prostate gland. In another embodiment, retainer 10 isdeployed between the 4 o'clock and 8 o'clock position relative to theaxis of the urethra to target the middle lobe of the prostate gland.

FIG. 1C shows a side view of one embodiment of the retainer shown inFIG. 1B. FIG. 1C shows retainer 10 comprising distal anchor 12 andproximal anchor 14. Distal anchor 12 and proximal anchor 14 areconnected by connector 16. In the embodiment shown in FIG. 1C, distalanchor 12 comprises a tube 18 having a lumen. Tube 18 can be made ofsuitable elastic or non-elastic materials including, but not limited tometals, polymers, etc. Typical examples of such materials include, butare not limited to stainless steel 304, stainless steel 316,nickel-Titanium alloys, titanium, Pebax, Polyimide, braided Polyimide,Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, PTFE, PFA, FEP, EPTFE,shape memory polymers, such as polyesterurethane, polyetherurethane,polyetherpolyesters, polyetherpolyamines or combinations of oligoe-caprolactore diol and oligo p-dioxanone diol polymers, etc. Connector16 is attached to tube 18. In one embodiment, connector 16 is a USP size0 polypropylene monofilament suture. In the embodiment shown in FIG. 1C,a distal region of connector 16 is located in the lumen of tube 18 suchthat the distal tip of connector 16 emerges out of one end of the lumenof tube 18. The distal tip of connector 16 is enlarged, such that thediameter of the enlarged distal tip of connector 16 is greater than theinner diameter of tube 18. In one embodiment, the diameter of connector16 is 0.014 inches and the diameter of the enlarged distal tip ofconnector 16 is 0.025 inches. In one embodiment, the enlarged distal tipof connector 16 is created by controlled melting of the distal tip ofconnector 16. This attaches connector 16 to tube 18. Tube 18 maycomprise one or more additional attachment mechanisms to attach a distalregion of connector 16 to tube 18. In one embodiment, the distal regionof connector 16 is attached to tube 18 by a suitable biocompatibleadhesive. In the embodiment shown in FIG. 1C, the distal region ofconnector 16 is attached to tube 18 by one or more inwardly openingflaps 20 that are cut in the material of tube 18. Flaps 20 gripconnector 16 and thus prevent the relative motion of connector 16 andtube 18. The angle between one of flaps 20 and connector 16 may rangefrom 1 degree to 90 degrees. Tube 18 further comprises a longitudinalslot 22. Longitudinal slot 22 extends from one end to roughly the midsection of tube 18. Connector 16 emerges out of this longitudinal slot22. Thus, when connector 16 is pulled in the proximal direction, distalanchor 12 assumes a T-shape that helps to anchor distal anchor 12 to ananatomical structure. Distal anchor 12 may comprise a sharp edge to helppenetrate distal anchor 12 through the anatomy. In a preferredembodiment, distal anchor 12 is constructed by laser cutting andelectropolishing a nickel-titanium alloy (e.g., nitinol) tube made of50.8% nickel-49.2% titanium. In the preferred embodiment, the outerdiameter of tube 18 is 0.026 inches, the inner diameter of tube 18 is0.015 inches, the length of tube 18 is 0.315 inches and the length oflongitudinal slot 22 is 0.170 inches.

In the embodiment shown in FIG. 1C, proximal anchor 14 comprises a tube24 comprising a lumen. Tube 24 can be made of suitable elastic ornon-elastic materials including, but not limited to metals, polymers,etc. Typical examples of such materials include, but are not limited tostainless steel 304, stainless steel 316, nickel-Titanium alloys,titanium, Pebax, Polyimide, braided Polyimide, Polyurethane, Nylon, PVC,Hytrel, HDPE, PEEK, PTFE, PFA, FEP, ePTFE, such as polyesterurethane,polyetherurethane, polyetherpolyesters, polyetherpolyamines orcombinations of oligo e-caprolactone diol and oligo p-dioxanone diolpolymers, etc. An outwardly opening flap 26 is cut through the materialof tube 24. Flap 26 is folded on the outer surface of tube 18 as shownin FIG. 1C. This creates an opening to the lumen of tube 24 that islined by the atraumatic edge of the folded flap 26. Connector 16 enterstube 24 through this opening to the lumen of tube 24. Proximal anchor 14further comprises an attachment mechanism to attach connector 16 to tube24. Connector 16 can be made of suitable elastic or non-elasticmaterials including, but not limited to metals, polymers, etc. Otherproximal anchor and distal anchor concepts are within the scope of theinvention, such as v-shaped proximal anchors that are press fit onto aconnector. Typical examples of such materials include, but are notlimited to stainless steel 304, stainless steel 316, nickel-Titaniumalloys, suture materials, titanium, silicone, nylon, polyamide,polyglycolic acid, polypropylene, Pebax, PTFE, ePTFE, silk, gut, or anyother braided or mono-filament material. In a preferred embodiment, tube24 has a length of 0.236 inches and an outer diameter of 0.027 inchesand an inner diameter of 0.020 inches. The length of opening to thelumen of tube 24 is approximately 0.055 inches. In the preferredembodiment, the attachment mechanism comprises a lock pin thatfrictionally attaches connector 16 to tube 24. The lock pin and tube 24are made of stainless steel 316L. In the preferred embodiment, tube 24is laser cut or stamped and then electropolished. Lock pin isconstructed using EDM (electrical discharge machining) and thenpassivated.

FIGS. 1D through 1J show the various steps of a method of treating aprostate gland by the retainer shown in FIG. 1C. Similar methods may bealso used to deploy retainer or compression devices in other anatomicalstructures. In the step shown in FIG. 1D, a sheath 28 such as a standardresectoscope sheath is introduced into the urethra (trans-urethrally).Sheath 28 is advanced through urethra UT such that the distal end ofsheath 28 is positioned near a region of urethra UT that is obstructedby a hypertrophied prostate gland PG. Distal anchor delivery device 30is introduced through sheath 28. Distal anchor delivery device 30 can beplaced in the sheath 28 after the distal end of sheath 28 is positionednear the region of the urethra UT that is obstructed or the distalanchor delivery device 30 can be pre-loaded in the sheath 28 beforepositioning of the sheath 28. Distal anchor delivery device 30 isadvanced through sheath 28 such that the distal end of distal anchordelivery device 30 emerges out of the distal end of sheath 28. Distalanchor delivery device 30 is oriented such that a working channelopening of distal anchor delivery device 30 points towards a laterallobe of prostate gland PG.

In the step shown in FIG. 1E, a needle 32 is introduced through distalanchor delivery device 30. Needle 32 can be placed in distal anchordelivery device after the distal anchor delivery device 30 is advancedthrough sheath 28 or the needle 32 can be pre-loaded in the distalanchor delivery device 30. In one embodiment, needle 32 is a 20 gaugeneedle. Needle 32 is advanced through distal anchor delivery device 30such that it emerges through the working channel opening. Needle 32 isfurther advanced such that it penetrates through the tissue of prostategland PG and the distal end of needle 32 emerges out of the capsule ofprostate gland CP.

In the step shown in FIG. 1F, distal anchor 12 connected to connector 16is advanced through needle 32. Distal anchor 12 can be pre-loaded inneedle 32 or can be loaded in needle 32 after needle 32 has beenadvanced through distal anchor delivery device 30. Distal anchor 12 isadvanced through needle 32 such that it emerges out of the distal end ofneedle 32. In alternate embodiments, the distal anchor can be held inplace by a pusher or connector while the needle is retracted, thusexposing the distal anchor.

In the step shown in FIG. 1G, needle 32 is removed from distal anchordelivery device 30 by pulling needle 32 in the proximal direction.

In the step shown in FIG. 1H, distal anchor delivery device 30 isremoved from sheath 28 by pulling distal anchor delivery device 30 inthe proximal direction. Also, connector 16 is pulled to orient distalanchor 12 perpendicularly to connector 16.

In the step shown in FIG. 1I, connector 16 is passed through proximalanchor 14 located on a proximal anchor delivery device 34. Proximalanchor delivery device 34 is advanced through sheath 28 such that thedistal end of proximal anchor delivery device 34 emerges out of thedistal end of sheath 28. A desired tension is introduced in connector 16such that distal anchor 12 is pulled by connector 16 with a desiredforce. Alternatively, the proximal anchor can be visualized through anendoscope or under fluoroscopy and advanced along the connector untilthe desired retraction of the tissue is achieved. In other embodiments,the proximal anchor is a v-shaped or clothespin-shaped piece that isforced, in some cases at high speed, onto the connector to fixedlyengage the connector.

In the step shown in FIG. 1J, connector 16 is attached to proximalanchor 14. Proximal anchor 14 is also released from proximal anchordelivery device 34, thus deploying proximal anchor 14 in the anatomy.Proximal anchor delivery device 34 and sheath 28 are removed form theanatomy. Retainer 10 comprising distal anchor 12, proximal anchor 14 andconnector 16 is used to retract, lift, support, reposition or compress aregion of prostate gland PG located between distal anchor 12 andproximal anchor 14. This method may be used to retract, lift, support,reposition or compress multiple regions or lobes of the prostate glandPG. In the method shown in FIGS. 1D through 1J, distal anchor 12 isdeployed on the outer surface of the capsule of prostate gland CP. Thus,distal anchor 12 acts as a capsular anchor. Alternatively, distal anchor12 may be deployed inside the tissue of prostate gland PG or beyond theprostate as outlined previously. Similarly, in the method shown in FIGS.1D through 1J, proximal anchor 14 is deployed on the inner wall ofurethra UT and acts as a urethral anchor. Alternatively, proximal anchor14 may be deployed inside the tissue of prostate gland PG.

The tissue approximation anchor shown in FIG. 1C is designed to beuseable in a physician's clinical office environment (in contrast torequiring a hospital environment) with a delivery tool. The deliverytool is used through a 19 F or 20 F sheath in one preferred embodiment.Additionally, the material selection and construction of the tissueapproximation anchor still allows for a subsequent TURP procedure to beperformed, if necessary, on the prostate. In this suture-based, tissueapproximation technique, a needle delivery mechanism is used to implantan anchor assembly.

Referring now to FIGS. 2-4, there is shown one embodiment of a deliverydevice 100. This device is configured to include structure that iscapable of both gaining access to an interventional site as well asassembling and implanting one or more anchor assemblies or implantswithin a patient's body. The delivery device 100 can be configured toassemble and implant a single anchor assembly or implant a single bodiedanchor or multiple anchors or anchor assemblies. The device is furthercontemplated to be compatible for use with a 19 F or 20 F sheath. Thedevice additionally includes structure configured to receive aconventional remote viewing device (e.g., an endoscope) so that thesteps being performed at the interventional site can be observed.

Prior to use of the present device 100, a patient typically undergoes afive day regimen of antibiotics. A local anesthesia can be employed forthe interventional procedure. A combination of an oral analgesic with asedative or hypnotic component can be ingested by the patient. Moreover,topical anesthesia such as lidocaine liquids or gel can be applied tothe bladder and urethra.

The anchor delivery device 100 includes a handle assembly 102 connectedto elongate member 104. Elongate member 104 can house componentsemployed to construct an anchor assembly and is sized to fit into a 19 For 20 F cystosopic sheath for patient tolerance during a procedure inwhich the patient is awake rather than under general anesthesia. Theassembly is intended to include structure to maintain its positioningwithin anatomy.

The anchor delivery device 100 further includes a number ofsubassemblies. A handle case assembly 106 including mating handle partsthat form part of the handle assembly 102. The handle assembly 102 issized and shaped to fit comfortably within an operator's hand and can beformed from conventional materials. Windows can be formed in the handlecase assembly 106 to provide access to internal mechanisms of the deviceso that a manual override is available to the operator in the event theinterventional procedure needs to be abandoned.

In one embodiment, the delivery device 100 is equipped with variousactivatable members that facilitate assembly and delivery of an anchorassembly at an interventional site. A needle actuator 108 is providedand as described in detail below, effectuates the advancement of aneedle assembly to an interventional site. In one approach, the needleassembly moves through a curved trajectory and exits the needle housingin alignment with a handle element, and in particular embodiments, inalignment with the grip. In various other embodiments, the needlehousing is oriented such that the needles exits the housing at eitherthe two o'clock or ten o'clock positions relative to a handle grip thatis vertical. A needle retraction lever assembly 110 is also provided andwhen actuated causes the needle assembly to be withdrawn and expose theanchor assembly.

In one particular, non-limiting use in treating a prostate, the elongatemember 104 of a delivery device is placed within a urethra (UT) leadingto a urinary bladder (UB) of a patient. In one approach, the deliverydevice can be placed within an introducer sheath (not shown) previouslypositioned in the urethra or alternatively, the delivery device can beinserted directly within the urethra. When employing an introducersheath, the sheath can be attached to a sheath mount assembly (describedbelow). The patient is positioned in lithotomy. The elongate member 104is advanced within the patient until a leading end thereof reaches aprostate gland (PG). In a specific approach, the side(s) (or lobe(s)) ofthe prostate to be treated is chosen while the device extends throughthe bladder and the device is turned accordingly. The inside of theprostate gland, including the adenoma, is spongy and compressible andthe outer surface, including the capsule, of the prostate gland is firm.By the physician viewing with an endoscope, he/she can depress theurethra into the prostate gland compressing the adenoma and creating thedesired opening through the urethra. To accomplish this, the physicianrotates the tool. The physician then pivots the tool laterally about thepubic symphysis PS relative to the patient's midline.

The delivery device is at this stage configured in a ready state. Theneedle actuator 108 and the needle retracting lever 110 are in aninactivated position.

Upon depression of the needle actuator 108, the needle 230 (See FIG. 4)is advanced from within the elongate member 104. The needle can beconfigured so that it curves back toward the handle as it is ejected. Inuse in a prostate intervention, the needle is advanced through andbeyond a prostate gland (PG). Spring deployment helps to ensure theneedle passes swiftly through the tough outer capsule of the prostatewithout “tenting” the capsule or failing to pierce the capsule. In oneapproach, the needle is made from Nitinol tubing and can be coated withParylene N. Such a coating helps compensate for frictional orenvironmental losses (such as wetness) that may degrade effectiveness ofneedle penetration.

Certain anchor delivery devices include springs as part of themechanisms that drive a needle or penetrating member, deploy an anchor,cut a connector, or perform other functions related to device delivery.The devices may include springs that are preloaded with potential energywhen the user removes the device from packaging. Preloaded springs canbe susceptible to degradation over time when stored in a loaded state,whether that state is tension or compression. Spring degradation mayaffect a device's shelf life. Also, spring degradation can affect theconsistency of the device as the spring force can change over time.Further, loaded components may creep due to constant stress.

FIG. 5 illustrates one embodiment of a handle assembly that does notpre-load energy in springs while the device is in a stored state. Handleassembly 600 includes two springs a needle drive spring 610 and a resetspring 620. Neither the needle drive spring 610 nor the reset spring 620stores potential energy in their stored state. That is, the springs andcomponents are not under stress from spring loading during shipping orstorage of the device.

A user loads energy into the needle drive spring 610 using a firstactuator 650, which can be a lever or trigger. In this embodiment, theuser can squeeze the first actuator 650 like a trigger. The firstactuator 650 pivots at pivot point 651 and causes needle drive traveler655 to compress both needle drive spring 610 and a reset spring 620.When the needle drive spring 610 is loaded with sufficient energy todrive the needle (not pictured) through the target tissue, the needledrive spring 610 is released by the mechanical action of the needledrive traveler 655. For example, a ramp 656 can disengage a latch 662 ona needle drive assembly 600 and allow the needle drive spring 610 tounload its stored energy and drive the needle. Other latching mechanismsare also within the scope of the invention.

The return spring 620, which is loaded when the first actuator 650 isactivated by the user, has sufficient energy to force the needle driveassembly 660 back into its original position. Returning needle driveassembly 660 to its original position includes forcing the latch 662back into its latched position. Further, returning the needle driveassembly 660 to its original position also works to retract the needle.While FIG. depicts the needle drive spring 610 and the return spring 620as being loaded by compression, one or both could be loaded by tension,and the system can achieve the same end. This embodiment provides asystem for: (1) avoiding stored energy in the springs of the deliverydevice and (2) returning the needle drive mechanism to its initialstate, including retracting the needle.

In another embodiment, the needle drive assembly is returned to itsinitial state and the needle is retracted by the action of a returnspring. As illustrated schematically in FIG. 6, the deployment spring710 is loaded by the user activating a first actuator (not pictured),such as a lever or a trigger. A deployment pawl 715 restricts the motionof the needle drive assembly 760 until the first actuator reaches apoint in its travel such that it disengages the deployment pawl 715. Thedeployment pawl 715 can be disengaged by a variety of mechanicalmethods, including the latching/unlatching mechanism described above.When the deployment pawl 715 is disengaged, the needle drive assembly760 drives the needle (not pictured) and loads the return spring 720.Further, as the needle drive assembly 760 drives the needle, a returnpawl 725 engages the proximal section of the needle drive assembly 760and the deployment spring 710 can optionally decouple from the needledrive assembly 760.

To load the return spring 720, the deployment spring 710 must haveenough load to both drive the needle with the desired force and to loadthe return spring 720. Advantageously, the load required by the returnspring 720 to withdraw the needle can be significantly less than thedrive load because the needle is being retracted. That is, the driveload may have to be large enough to initially penetrate tissue andovercome frictional forces in the distal section of the delivery system.However, the return spring 720 does not need load to penetrate tissueand the frictional forces on the return of the needle are lower thanupon initial drive.

The return pawl 725 is released by the user, or optionally by mechanicalaction prompted by the first actuator, to retract the needle using theload of the return spring 720. In some embodiments, it may be desirableto allow the user to release the return pawl 725 and in others thereturn pawl 725 is released directly engaging the user in a stepindependent from using the first actuator. The return spring 720 canreturn the needle drive assembly past the deploy pawl 715. Thus, thesystem is returned to its initial state where the deploy spring 710 canbe loaded again by the first actuator.

The anchor delivery system uses a needle or other penetrating member todeploy anchors within tissue. In some deployments, the needle may strikebone tissue, calcification, or other objects or surfaces that causedamage to the needle or needle tip. For an anchor delivery deviceconfigured to deploy multiple anchor assemblies via multiple needleadvancements, a damaged needle can cause complications in deployment.

In certain embodiments, the mechanical integrity of a multi-use needleis assessed by a mechanism in the distal section of the delivery device.FIG. 7A illustrates a curved section of a needle tube 235 and a needle230 within the needle tube 235. In this embodiment, the needle tube 235includes a window 236 on the outer portion 231 of the curvature of theneedle tube 235. Since the needle 230 engages the outer portion 231 ofthe curvature as that section of the needle tube 235 directs the needle230 around the curve, a defect on the needle 230 such as a missing,kinked, or bent tip will cause the needle 230 to partially enter thewindow 236 and engage on side of the window 236. FIG. 7B illustrates analternative embodiment in which a lip 237 inside the outer portion 231of the curvature can similarly engage the end of a needle 230 with adefect such as a missing, kinked, or bent tip. Thus, a needle 230 with amissing, kinked, or bent tip will be stopped from advancing and theneedle stopping will alert the user of the needle defect.

In certain embodiments, the integrity of the needle can be visuallyassessed via the cystoscope. After a deployment, the needle can bepartially retracted such at it is in the field of view of the cystoscopeand the integrity of the needle can be directly observed by the user.

In certain embodiments, at least part of the elongate member 104 of thedelivery device can be formed by injection molding a two-part, clamshell styled design. The two parts can be joined by press fit, snap fit,adhesives, solvent, overmold, shrink tubing, or other equivalentmethods. FIG. 8 illustrates a comparison of the cross-sections of anelongate member 104 assembled from tubes and a channel versus thetwo-part injection molded elongate member 104′. Both cross-sectionscontain a cystoscope lumen (104 a, 104 a′), a needle lumen (104 b, 104b′), and an anchor lumen (104 c, 104 c′). The clam-shell design can beincorporated along some or all of the length of the elongate member104′. An injection molded section 104 can be created with a single partthat does not require joining. The lumens can be made with alternatingshut-offs in the mold, or alternatively, the lumens are not closedlumens. Rather, the lumens of the elongate member 104 provide sufficientconstraint to the members that traverse within without using fullcircumference lumens. Such embodiments enable a less complicated mold.

In other embodiments, one or more of the parts of the two part design isstamped. The stamped parts can be joined by press fit, snap fit,adhesives, solvent, overmold, shrink tubing, or other equivalentmethods. Alternatively, the entire elongate member 104 could be a singlestamped part with lumens that are not closed, but rather provide onlyenough constraint to the members that traverse within to keep thosemembers within the lumens, but with non-closed lumens enable lesscomplex stamping tooling.

In certain embodiments, at least part of at least one of the threelumens of the elongate member can be eliminated. In one embodiment,shorter tube segments can replace an entire tube segment. For example,the needle tube can be replaced with a short tube segment in theproximal handle and at the distal end such that the needle isconstrained near its ends but does not require a lumen for a substantialpart of the mid-section of the needle. Clips or flanges could be used inaddition to or in place of the short tubes. Alternately, the cystoscopetube can be eliminated and replaced with tubes or clips or flanges.

In some embodiments, the elongate member is detachable and reusable,while the proximal handle is single use. The proximal handle can storethe implants as well as provide the loads necessary to drive the needle,deliver the anchors, and cut the connector. Also, the shaft may housemultiple anchor components and may house the needle.

The method of use of the anchor delivery system can incorporate the useof a cyctoscope, endoscope, or similar visualization device. In someembodiments, the proximal handle includes a scope lock with no movingparts for locking a cystoscope to the handle prior to performing thetreatments disclosed herein. The lack of moving parts reduces the costand increases the reliability and ease of use.

FIG. 9. illustrates a scope lock 800 according to certain embodiments.The scope lock includes a pair of stops (810, 812) at about 3 o'clockand about 9 o'clock. A scope is inserted with the light post betweenthese two stops 810, 812 on the 12 o'clock side of the scope lock circlesuch that the scope cannot be twisted downward with respect to stops 810and 812 so that the light post is toward the 6 o'clock position. Thescope can now only be twisted towards the 12 o'clock position. The scopelock further includes a pair of flexible ramp features (820, 822). Thelight post of the cystoscope rotates up one or the other of these ramps(820, 822) and snaps into the 12 o'clock position. The snap fit isstrong enough such that the user may rotate the camera relative to thescope but not overpower the stop portions of the ramps.

In some embodiments, a movable lens or electronic image sensor can beintegrated into an endoscopic telescope for a disposable device intowhich a telescope is inserted. Alternatively, more than one lens can bepositioned on a telescope and electronically selected to providedifferent views from the telescope. A movable lens or more than onelens, advantageously, can provide views in different directions, atdifferent magnifications, or differently sized fields of view. Suchlenses or image sensors can be integrated with a standard telescope in avariety of ways. For example, the telescope could be a standardtelescope and the movable lens could be on the delivery device such thatwhen the telescope and the delivery device are mated together adjustingthe lens on the delivery device provides a variety of images to thetelescope. Alternatively, the lens on the delivery device could beexchangeable to provide different views. In another example, anadjustable-position image sensor could be used integrally with thedelivery device to capture the image. Finally, a prism could be used toprovide multiple views to the telescope and electronic image processingcould be used to provide stereo, compound, or selective partial imagingto the user.

In some embodiments, the first anchor is delivered via a needle tipplaced at the end of a wire. Needle tip can be attached to the wire bypress fit, snap fit, adhesives, solvent, overmold, shrink tubing, orother equivalent methods. The connector can run along the side of theanchor delivery wire. Advantageously, using a wire rather than a needlefor travel along a substantial section of the needle tube reduces thecost of the needle assembly. Only the needle tip is hollow.

In some embodiments, a tape-like or ribbon-like needle or wire is usedin the needle assembly. Advantageously, a ribbon-like needle willpreferentially to bend to tighter radius in one direction than inanother direction. Thus, the needle can have sufficient column strengthfor penetrating tissue while also having sufficient flexibility in adirection in which flexibility is desired.

As best shown in FIGS. 10 and 11, an embodiment of the cutter assembly514 includes elongate cutter tube 562. A distal end 568 of the cuttertube 562 is configured with a blade 569 so that once the cutter assembly514 is withdrawn, the blade can sever as desired a connector of ananchor assembly. In one particular embodiment, the cutter 514 can beformed from ground 17-4 PH stainless steel blank. Various structures arecontemplated for incorporation into the cutter assembly to facilitate aclean severing of a connector as well as to aid in assembling a proximalcomponent of an anchor assembly to the connector. For example, as bestseen in FIG. 11, the cutter blade 569 includes a coined out undersidethat is intended to be offset from a bottom side of a proximal anchor byabout 0.0035+0.0010 inches to cut a nominal 0.015 inch diameterconnector. In this way, the proximal anchor can exit a cutter withoutdeforming or compressing a suture or connector tag, and the strength ofthe connector to anchor connection is maintained. Alternatively, thefeature that cuts the suture can by a non-sharp feature. Therefore,instead of cutting via a blade, it could cut the suture through ashearing action where two non-sharp elements slide past each other andcreate a shearing action through the suture.

As shown in FIGS. 12-14, the cutter 514 can define a generallyrectangular elongate single body that can be formed by stamping andbending. An interior of the body is sized and shaped to receive aproximal anchor component 550. A proximal end portion of the cutter 564can further include anti-buckling tabs 551 and extensions 553 intendedto snap fit to a cutter block (described below). Lance-out structures555 are also contemplated to be spaced along the cutter body whichfacilitate alignment of the cutter 514 within the shaft assembly.

To eliminate snagging of a connector, walls defining a needle window 557formed in the cutter 514 can be contoured to help properly guide theconnector into a suture capture area 559. As best seen in FIG. 15, aproximal portion of the needle window 557 defines a gradual slope fordirecting the connector within the capture area 559. In a relatedapproach (FIG. 16), bumps 561 can be formed on connector guidingstructure to further aid in properly positioning a connector 352 forengagement with a proximal anchor component 555.

Moreover, as depicted in FIGS. 17 and 18, the cutter 214 can furtherinclude skew limiting projections 563 extending internally within thegenerally tubular cutter 214. As best seen in FIG. 18, the projections563 help to maintain proper positioning of a proximal anchor component555 within the cutter 214.

In a further aspect illustrated in FIGS. 19-20, the present device caninclude a suture alignment slide 570 configured to slide under a cover571 and over the cutter 514. The cover 571, in turn, includes a fingerprojector 573 which is sized and shaped to control and guide themovement of a proximal anchor 555. The alignment slide 570 indexes theconnector 352 to a centerline of the cutter 514. It also operates topull the connector 352 proximally for indexing within the proximalanchor component 555 to thus enhance connector capture by the anchorcomponent 555. In other embodiments, a distal end of the needle housingitself can alternatively or additionally include a slot or notch forproperly registering the connectors during device use and particularlywhen tension is being applied to the connector.

In order to accomplish the attachment of the proximal anchor 555 to theconnector 352, a pusher assembly 575 is configured to extend within thecover 571 (See FIGS. 21-23). The pusher assembly 525 can include aproximal portion 577 which extends to the handle of the device(connected to pusher block as described below) and a distal portion 579which attaches to the proximal portion 577. The distal portion 579 canfurther include an extension 581 sized to receive the length of aproximal anchor 555. The thickness of the extension 581 is chosen toensure a 0.004 inch gap between a cutter and a bottom portion of theproximal anchor 555 so that a connector tag remains after its severingby the cutter. The cover 571 can further include an anchor stop 583,which is configured at a distal end of the cover 571. The anchor stop583 is sized and shaped to protect the proximal anchor 555 from becomingtrapped within the cover 571 after its engagement with the proximalanchor 555. Through its connection to the pusher of the pusher block604, the pusher assembly 575 is advanced distally which, in turn,results in the proximal anchor component 555 engaging the connector 352(See also FIG. 23).

Next, the pusher block 604 contacts a first end of the cutter pawl 608causing its second end to rotate away from the engagement with thecutter block 565. It is to be noted that the timing of first advancing aproximal anchor component 555 and then cutting a connector 352 to lengthcan be controlled by the force applied by the spring 606, the distancethe pusher block 604 is to travel, and/or the location of the first endof the cutter pawl 608. A proximal end of the cutter 214 is attached tothe cutter block 565. As the cutter block 565 moves proximally, thecutter 214 is withdrawn.

Accordingly, release of the pusher assembly advances the secondcomponent 555 of an anchor assembly into locking engagement with aconnector of an anchor assembly (See FIG. 23). Such action causes thepusher 575 to advance the anchor component 555 onto a connector (e.g., asuture) while the connector is being held by the tool with sufficientforce and the anchor is advanced with sufficient speed and force to seatthe anchor 555 with reliable retention force.

In another embodiment, the pusher assembly 575 for pushing the secondanchor component 14 is eliminated by using a single assembly thatengages the second anchor 14 with the connector 352 and also cuts theconnector 352. FIG. 24A illustrates the second anchor 14 and the cutterblock 565 in position to engage the second anchor 14 after the connector352 has been tensioned. FIG. 24B illustrates the cutter block 565 beingpushed distally by an actuator (which activates a load supplied by aspring or gas or other loading methods described herein). The secondanchor component 14 is engaged to the connector 352 during the distaldriving step. FIG. 24C illustrates the cutter block 565 being pulledproximally by any of the return or retract mechanisms described herein.The second anchor component 14 remains fixed relative to the movement ofthe cutter block 565 since the second anchor component 14 is engagedonto the connector 352. FIG. ED illustrates the connector 352 havingbeen cut by the sharp edge of the cutter block 565. FIG. EE depicts thesecond anchor component 14 attached to the connector 352 and theconnector 352 having been cut.

In alternative embodiment, the second anchor can be held in position viatension, for example, during retraction of a cutter with a relativelydull edge. The cutter would help seat the second anchor on the connectorprior to the connector being cut.

In some embodiments, one or more springs are replaced with a gas-drivenmechanism. The mechanism can be driven by gas canisters, such as a CO₂canister, or it can be driven by a compressed gas system, such as acompressed air line or a compressed gas tank, or by suction or fluidlines. One or more of the steps of needle deployment, connectortensioning, second anchor component attachment, and connector cuttingcan be powered by the gas-driven mechanism. The gas-driven system caninclude bleed valves, regulators, pistons, and other fluid controlstypically associated with gas-powered devices.

In certain embodiments, the friction between the needle tube (or itsequivalent structure in embodiments of the various elongate membersdisclosed herein) and the needle must be overcome by the energy loadthat drives the needle. Reducing the friction experience by the needle,particularly at the curvature in the distal section of the needleassembly, can reduce the load required to advance the needle. In certainembodiments, even though the needle is formed with a curved section atits distal end, the radius of curvature of the distal section of theneedle assembly is tighter than the radius of curvature of the curveddistal section of the needle. The curvature of the needle is less tightto provide a generally orthogonal track from the prostatic capsule tothe prostatic urethra. A greater curve in the distal end of the needlecould create difficulties in seating the distal anchor on the prostaticcapsule. Further, the needle assembly has to redirect the needle in arelatively small amount of space due to the low profile of the deliverysystem. Thus, its radius should be as tight as possible. Balancing theseopposing requirements while closely aligning the radii can reduce thefriction experienced by the needle. In some embodiments, the radius ofthe needle is about 0.957″ while the inner and outer radii of the needletube are 0.805″ and 0.802″, respectively.

FIGS. 25A-H illustrates various views of an anchor delivery systemhandle 1000 configured to accept cartridges 1200. Each cartridge 1200contains at least one anchor assembly. The anchor delivery system handle1000 is configured to deliver the anchor assembly and return to a loadedstate such that the spent cartridge can be replaced with a new cartridgeand the deployment process can be repeated without requiring the user toload mechanical energy into the springs within the device.

Preferably, the device is stored and shipped with some or all of thesprings not storing mechanical energy. A removable insert can beincluded in the cartridge chamber 1010 of the anchor delivery systemhandle 1000. After opening the package containing the anchor deliverysystem handle 1000, the user must remove the insert before there isspace in the anchor delivery system handle 1000 for inserting a newcartridge 1200. The removable insert and the anchor delivery systemhandle 1000 are configured such that removing the removable insert loadsthe spring 1050 or springs 1050, 1055 in the system with an initialenergy load and positions the firing sled 1060 in the cartridge chamber1010 to accept the new cartridge 1200. For example, the user can pull ina proximal direction on a handle on the removable insert until theinsert reaches a point in the cartridge chamber 1100 that allows theuser to remove the insert. The removable insert can be pulled out whenit clears protrusions, cuts, or other structural features in the anchordelivery system handle 1000.

The firing sled 1060 includes slots that align with pusher tabs 1012,1014 on cartridge 1200. The slots and pusher tabs are complementarymechanisms that allow the transfer of energy from the spring 1050 viathe firing sled 1060 to fire the needle in the cartridge 1200. Thecartridge 1200 snaps into place within the cartridge chamber 1010 afterthe slots and pusher tabs are aligned or is locked in place with achamber door or latch.

To fire the needle from the distal end of cartridge 1200, safety 1085 issqueezed by the user. Squeezing the safety 1085 frees cam wheel 1100 torotate. Cam wheel 1100 is operatively connected to lever 1080 throughdrive gear 1150 and clutch 1130. Teeth on lever 1080 mesh with teeth ondrive gear 1150. Features on the drive gear 1150 mesh with features onthe clutch 1130. Because the clutch 1130 is mated with splines to thecam wheel 1100, the more force that is applied the greater the grippingforce will be. Once the lever 1080 is fully squeezed, is able to fullyretract to its original position without moving the cam wheel 1100. Whenthe lever 1080 is squeezed inward to its full travel stroke by the user,cam wheel 1100 rotates clockwise 180°. Rotation of the cam wheel 1100eventually releases firing sled 1060 such that the energy stored inspring 1050 causes firing sled 1060 move rapidly forward and drive theneedle out from the distal end of cartridge 1200 and into tissue. FIG.25D illustrates firing sled 1060 in its forward position in his needle230 is shown advanced from the distal end of the cartridge 1200.

As depicted in FIGS. 25E-25F, as the user continues to squeeze the lever1080 cam wheel 1100 continues to rotate and pulls back the firing sled1060. Connector sled 1020 remains in a forward position as the firingsled 1060 is pulled proximally, which ejects the distal anchor from theend of needle 230. With the remaining travel of lever 1080 as it issqueezed by the user, connector sled 1020 is pulled proximally by therotating cam wheel 1100 thereby putting tension on the connector. Thelever 1080 can now be released back to its initial position while thecomponents inside anchor delivery system handle 1100 remain in place.

As depicted in FIGS. 25G-25H, with a second squeeze of lever 1080 camwheel 1100 rotates and disengages a lock on second anchor sled 1040,which is connected to spring 1055. Spring 1055 has been loaded withenergy by the rotation of the cam wheel 1100 and now that energy isreleased through second anchor sled 1040 moving rapidly forward todeliver the second anchor to engage with the connector. This step offiring the second anchor sled 1040 distally also accomplishes cuttingthe connector through mechanisms disclosed herein.

As depicted in FIGS. 25I-25J, when the user continues to squeeze lever1080 the cam wheel 1100 continues to rotate and returns the secondanchor sled 1040 to which initial position. After the lever 1080 isreleased for the second time, the anchor delivery system handle 1000 isagain configured such that the spent cartridge 1200 can be removed and anew cartridge 1200′ can be inserted into the handle. The rotating camwheel 1100 has also returned safety 1085 to its a locked-out position.Alternatively, the lever 1080 and cam wheel 1100 can be configured torotate the cam wheel 120 degrees with each lever squeeze, requiringthree pulls of the lever 1080 to complete the deployment sequence andreturn to the start position. Alternatively, the cam wheel 1100 andlever 1080 (and gearing) can be designed to rotate the cam wheel unequalamounts with each lever squeeze. For example, in a three-lever pullconfiguration, the design could enable the first two lever pulls torotate the wheel 90 degrees each (achieving 180 degrees of rotationafter the first two pulls) and the third lever pull then completes theremaining 180 degrees of rotation.

FIGS. 26A-26E illustrate an anchor delivery system including a tipcartridge 2000. The tip cartridge 2000 includes a needle 230 and ananchor assembly including the first anchor the connector and the secondanchor. Firing shaft 2100 is configured to mate with a lumen on handleelongate member 2200. Locking arms 2010 also mate with handle elongatenumber 2200 and provide stability to the joint connecting handleelongate member 2200 and tip cartridge 2000. Activating an actuator onthe handle of the anchor delivery system forces firing shaft 2100distally and advances needle 230. The same or another actuator isactivated to retract the needle while maintaining the position of theconnector in the distal anchor such that both are deployed withintissue. The connector is tensioned, and the same or another actuatorfires the 2nd anchor to engage the connector. Advantageously, thisembodiment enables reuse of a single handle with multiple tipcartridges. This embodiment, and embodiments equivalent thereto,efficiently provide the anchor assembly to the distal end of the device.

In some embodiments, a cartridge includes an elongate shaft portion thatcan attach to the distal end of the scope or the distal end of thesheath. This distal point of attachment can help stabilize and/or securethe distal portion of the elongate portion of the cartridge before orafter the cartridge has been inserted into a handle. In someembodiments, a cartridge has structural features such as splines,bosses, arms, standoffs, or similar features that align thecross-sectional position of the cartridge within the sheath. Preferably,such features align the distal end of the cartridge with the distal endof the sheath. Further, the aligning features can be on the scope inaddition to or instead of on the cartridge. Preferably, the aligningfeatures permit irrigation fluid flow through the length of the sheath.In some embodiments, the handle need not be separated or adjustedrelative to the sheath in order to remove or install a cartridge. Insome embodiments, the cartridge is configured such that insertion orremoval of the cartridge changes the energy state of at least one of thespring mechanisms in the handle.

Embodiments described herein provide several advantages, including, butnot limited to, the ability to efficiently deliver multiple anchorassemblies while reducing patient discomfort and increasing ease-of-use.Certain embodiments provide mechanisms for, with a single lever orequivalent actuator, delivering an anchor assembly and recharging thestored energy in the delivery device such that the device is ready ornear ready to deliver another anchor assembly by simply replacing acartridge in the delivery system.

Accordingly, the present invention contemplates both pushing directly onanchor portions of an anchor assembly as well as pushing directly uponthe connector of the anchor assembly. Moreover, as presented above, thedistal or first anchor component can be advanced and deployed through aneedle assembly and at least one component of the proximal or secondanchor component is advanced and deployed from the needle or from ahousing portion of the anchor deployment device. Further, either asingle anchor assembly or multiple anchor assemblies can be deliveredand deployed at an intervention site by the deployment device.Additionally, a single anchor assembly component can for example, beplaced on one side of a prostate or urethra while multiple anchorassembly components can be positioned along an opposite or displacedposition of such anatomy. The number and locations of the anchorassemblies can thus be equal and/or symmetrical, different in number andasymmetrical, or simply asymmetrically placed. In the context ofprostate treatment, the present invention is used for the displacement,compression, and/or retraction of the prostate gland and the opening ofthe prostatic urethra, the delivering of an implant at theinterventional site, and applying tension between ends of the implant.Moreover, drug delivery is both contemplated and described as a furtherremedy in BPH and over active bladder treatment as well as treatingprostate cancer and prostatitis.

Once implanted, the anchor assembly of the present inventionaccomplishes desired tissue manipulation, approximation, compression orretraction as well as cooperates with the target anatomy to provide anatraumatic support structure. In one preferred embodiment, the shape andcontour of the anchor assembly is configured so that the assemblyinvaginates within target tissue, such as within folds formed in theurethra by the opening of the urethra lumen by the anchor assembly. Indesired placement, wispy or pillowy tissue in the area collapses aroundthe anchor structure. Eventually, the natural tissue can grow over theanchor assembly and new cell growth occurs over time. Such cooperationwith target tissue facilitates healing and avoids unwanted side effectssuch as calcification or infection at the interventional site.

Subsequent to the interventional procedure, the patient can be directedto take appropriate drugs or therapeutic agents, such as alpha blockersand anti-inflammatory medicines.

Furthermore, in addition to an intention to cooperate with naturaltissue anatomy, the present invention also contemplates approaches toaccelerate healing or induce scarring. Manners in which healing can bepromoted can include employing abrasive materials, textured connectors,biologics and drugs.

Additionally, it is contemplated that the components of the anchorassembly or selected portions thereof (of any of the anchor assembliesdescribed or contemplated), can be coated or embedded with therapeuticor diagnostic substances (e.g. drugs or therapeutic agents). Again, inthe context of treating a prostate gland, the anchor assembly can becoated or imbedded with substances such as 5-alpha-reductase which causethe prostate to decrease in size. Other substances contemplated includebut are not limited to phytochemicals generally, alpha-1a-adrenergicreceptor blocking agents, smooth muscle relaxants, and agents thatinhibit the conversion of testosterone to dihydrotestosterone. In oneparticular approach, the connector can for example, be coated with apolymer matrix or gel coating that retains the therapeutic or diagnosticsubstance and facilitates accomplishing the timed release thereof.Additionally, it is contemplated that bacteriostatic coatings as well asanalgesics and antibiotics for prostatitis and other chemical coatingsfor cancer treatment, can be applied to various portions of the anchorassemblies described herein. Such coatings can have various thicknessesor a specific thickness such that it along with the connector itselfmatches the profile of a cylindrical portion of an anchor member affixedto the connector. Moreover, the co-delivery of a therapeutic ordiagnostic gel or other substances through the implant deployment deviceor another medical device (i.e. catheter), and moreover an anchorassembly including the same, is within the scope of the presentinvention as is radio-loading devices (such as a capsular or distal endsof implants for cancer or other treatment modalities). In one suchapproach, the deployment device includes a reservoir holding the gelsubstance and through which an anchor device can be advance to pick up adesired quantity of therapeutic or diagnostic gel substance.

It is further contemplated that in certain embodiments, the anchordelivery device can include the ability to detect forces being appliedthereby or other environmental conditions. Various sections of thedevice can include such devices and in one contemplated approach sensorscan be placed along the needle assembly. In this way, an operator candetect for example, whether the needle has breached the targetanatomical structure at the interventional site and the extent to whichsuch breaching has occurred. Other sensors that can detect particularenvironmental features can also be employed such as blood or otherchemical or constituent sensors. Moreover, one or more pressure sensorsor sensors providing feedback on the state of deployment of the anchorassembly during delivery or after implantation are contemplated. Forexample, tension or depth feedback can be monitored by these sensors.Further, such sensors can be incorporated into the anchor assemblyitself, other structure of the deployment device or in the anatomy.

Moreover, it is to be recognized that the foregoing procedure isreversible. In one approach, the connection of an anchor assembly can besevered and a proximal (or second) anchor component removed from thepatient's body. For example, the physician can cut the connector andsimultaneously remove the second anchor previously implanted forexample, in the patient's urethra using electrosurgical, surgical orlaser surgical devices used in performing transurethral prostateresection.

An aspect that the various embodiments of the present invention provideis the ability to deliver an anchor assembly having a customizablelength, each anchor assembly being implanted at a different locationwithout having to remove the device from the patient. Other aspects ofthe various embodiments of the present invention are load-baseddelivery, of an anchor assembly, anchor assembly delivery with a devicehaving integrated connector, (e.g. suture), cutting, and anchor assemblydelivery with an endoscope in the device. The delivery device isuniquely configured to hold the suture with tension during delivery tohelp ensure that the first anchor component sits firmly against a tissueplane (e.g., the outer capsule of the prostate) and is held relativelyfirm as the second anchor component is attached to the connector and thedelivery device. In this aspect, the needle assembly acting as apenetrating member is cooperatively connected to a mechanism that pullson the anchor while the needle assembly is retracted.

It is to be recognized that various materials are within the scope ofthe present invention for manufacturing the disclosed devices. Moreover,one or more components such as distal anchor, proximal anchor, andconnector, of the one or more anchor devices disclosed herein can becompletely or partially biodegradable or biofragmentable.

Further, as stated, the devices and methods disclosed herein can be usedto treat a variety of pathologies in a variety of lumens or organscomprising a cavity or a wall. Examples of such lumens or organsinclude, but are not limited to urethra, bowel, stomach, esophagus,trachea, bronchii, bronchial passageways, veins (e.g. for treatingvaricose veins or valvular insufficiency), arteries, lymphatic vessels,ureters, bladder, cardiac atria or ventricles, uterus, fallopian tubes,etc.

Finally, it is to be appreciated that the invention has been describedhereabove with reference to certain examples or embodiments of theinvention but that various additions, deletions, alterations andmodifications may be made to those examples and embodiments withoutdeparting from the intended spirit and scope of the invention. Forexample, any element or attribute of one embodiment or example may beincorporated into or used with another embodiment or example, unless todo so would render the embodiment or example unpatentable or unsuitablefor its intended use. Also, for example, where the steps of a method aredescribed or listed in a particular order, the order of such steps maybe changed unless to do so would render the method unpatentable orunsuitable for its intended use. All reasonable additions, deletions,modifications and alterations are to be considered equivalents of thedescribed examples and embodiments and are to be included within thescope of the following claims.

Thus, it will be apparent from the foregoing that, while particularforms of the invention have been illustrated and described, variousmodifications can be made without parting from the spirit and scope ofthe invention.

We claim:
 1. A system for deploying an anchor assembly, comprising: acartridge having a needle configured to carry the anchor assembly,wherein the cartridge comprises a tab connected with the needle; ahandle comprising a sled connected to a spring mechanism and the sledincludes a slot, wherein the handle is configured to couple with thecartridge such that the slot on the sled aligns with the tab and theslot and the tab are a complementary mechanism that allows a transfer ofmechanical energy from the spring via the sled to the cartridge; and asingle actuator configured to initiate the transfer of the mechanicalenergy to cause the sled to move rapidly forward and drive the needleout from a distal end of the cartridge.
 2. The system of claim 1 whereinthe single actuator is configured to restore a majority of themechanical energy.
 3. The system of claim 2 wherein the single actuatoris configured to be activated more than one time to completely deploythe anchor assembly and restore the majority of the mechanical energy.4. The system of claim 2 wherein the single actuator is configured torestore mechanical energy to the at least one spring mechanismsufficient to deploy a second anchor assembly from a second cartridge.5. The system of claim 1 wherein the cartridge is removable from thehandle without releasing the mechanical energy in the spring mechanism.6. The system of claim 1 wherein the anchor assembly comprises a firstanchor, a connector, and a second anchor.
 7. The system of claim 1wherein the cartridge further comprises an elongate member configured toaccess an interventional site adjacent a prostate.
 8. The system ofclaim 1 where the anchor assembly includes a customizable-lengthconnector element.
 9. The system of claim 1 further comprising a scope,wherein the cartridge is configured such that insertion and removal ofthe cartridge can be completed without removal or adjustment to thescope.